LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company,
and Medison Pharma Ltd, Israel's leading commercial partner for
innovative pharmaceuticals, have entered into an exclusive agreement
under which Medison will commercialize NERLYNX® (neratinib) in Israel.
NERLYNX is not approved currently for commercialization outside of the
United States. Medison will be responsible for seeking the requisite
regulatory approval and, once approved, for commercializing NERLYNX in
Israel. Puma will receive upfront and milestone payments throughout the
term of this agreement, as well as significant double digit royalties on
NERLYNX sales in Israel.
“Our new agreement with Medison demonstrates our commitment to bringing
NERLYNX to patients around the world while continuing to focus our
commercial resources on the U.S. market,” stated Alan H. Auerbach, Chief
Executive Officer and President of Puma. “We are confident this new
partnership will help patients in Israel access NERLYNX at the earliest
opportunity.”
“We are excited about the opportunity to provide this therapy to women
in our region. We plan to expedite access to NERLYNX via an early access
program. In tandem, we plan to file for marketing authorization with the
Israeli Ministry of Health, and expect to receive regulatory approval
for NERLYNX in Israel during the first half of 2019,” said Meir
Jakobsohn, Chief Executive Officer and Founder of Medison Pharma.
“NERLYNX is highly complementary to our comprehensive portfolio, and
will further strengthen Medison's lead in the Israeli oncology market.”
Neratinib was approved by the U.S. Food and Drug Administration (FDA) in
July 2017 for the extended adjuvant treatment of adult patients with
early stage HER2-positive breast cancer following adjuvant
trastuzumab-based therapy, and is marketed in the United States as
NERLYNX® (neratinib) tablets.
About HER2-Positive Breast Cancer
Approximately 20% to 25% of breast cancer tumors over-express the HER2
protein. HER2-positive breast cancer is often more aggressive than other
types of breast cancer, increasing the risk of disease progression and
death. Although research has shown that trastuzumab can reduce the risk
of early stage HER2-positive breast cancer returning after surgery, up
to 25% of patients treated with trastuzumab experience recurrence.
IMPORTANT SAFETY INFORMATION
NERLYNX
®
(neratinib) tablets, for oral use
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated
for the extended adjuvant treatment of adult patients with early-stage
HER2 overexpressed/amplified breast cancer, to follow adjuvant
trastuzumab-based therapy.
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
-
Diarrhea: Aggressively manage diarrhea occurring despite
recommended prophylaxis with additional antidiarrheals, fluids, and
electrolytes as clinically indicated. Withhold NERLYNX in patients
experiencing severe and/or persistent diarrhea. Permanently
discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade
≥ 2 diarrhea that occurs after maximal dose reduction.
-
Hepatotoxicity: Monitor liver function tests monthly for the
first 3 months of treatment, then every 3 months while on treatment
and as clinically indicated. Withhold NERLYNX in patients experiencing
Grade 3 liver abnormalities and permanently discontinue NERLYNX in
patients experiencing Grade 4 liver abnormalities.
-
Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise
patients of potential risk to a fetus and to use effective
contraception.
ADVERSE REACTIONS: The most common adverse reactions (≥ 5%) were
diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis,
decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail
disorder, dry skin, abdominal distention, epistaxis, weight decreased
and urinary tract infection.
To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology,
Inc. at 1-844-NERLYNX (1-844-637-5969) and
www.NERLYNX.com
or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch
DRUG INTERACTIONS:
-
Gastric acid reducing agents: Avoid concomitant use with proton pump
inhibitors (PPI) and H2-receptor antagonists. Separate NERLYNX by 3
hours after antacid dosing.
-
Strong or moderate CYP3A4 inhibitors: Avoid concomitant use.
-
Strong or moderate CYP3A4 inducers: Avoid concomitant use.
-
P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of
narrow therapeutic agents that are P-gp substrates when used
concomitantly with NERLYNX.
USE IN SPECIFIC POPULATIONS:
-
Lactation: Advise women not to breastfeed.
Please see
Full
Prescribing Information
for additional safety information.
The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given
orally once daily with food, continuously for one year. Antidiarrheal
prophylaxis should be initiated with the first dose of NERLYNX and
continued during the first 2 months (56 days) of treatment and as needed
thereafter.
To help ensure patients have access to NERLYNX, Puma has implemented the
Puma Patient Lynx support program to assist patients and healthcare
providers with reimbursement support and referrals to resources that can
help with financial assistance. More information on the Puma Patient
Lynx program can be found at www.NERLYNX.com
or 1-855-816-5421.
About Puma Biotechnology
Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on
the development and commercialization of innovative products to enhance
cancer care. The Company in-licenses the global development and
commercialization rights to three drug candidates — PB272 (neratinib
(oral)), PB272 (neratinib (intravenous)) and PB357. NERLYNX® (neratinib)
is approved for commercial use by prescription in the United States as
extended adjuvant therapy for early stage HER2-positive breast cancer
following adjuvant trastuzumab-based therapy and is marketed as NERLYNX.
Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks
signal transduction through the epidermal growth factor receptors, HER1,
HER2 and HER4. Currently, the Company is primarily focused on the
commercialization of NERLYNX and the continued development of its other
advanced drug candidates directed at the treatment of HER2-positive
breast cancer. The Company believes that NERLYNX has clinical
application in the potential treatment of several other cancers that
over-express or have a mutation in HER2.
Further information about Puma Biotechnology can be found at www.pumabiotechnology.com.
About Medison
Medison, Israel’s leading innovative pharmaceutical partner, is an
exclusive Israeli partner for global healthcare companies such as
Amgen®, Biogen®, Ipsen®, Servier®, Array Biopharma® and more. Backed by
three generations of experience in the healthcare industry since 1937,
Medison has built and maintained long-standing relations with HMOs,
local medical centers and physicians. Medison is uniquely qualified to
provide the complete spectrum of integrated services for international
companies looking to enter or expand their presence in the Israeli
market.
Additional information can be found at www.medison.co.il.
Forward-Looking Statements
This press release contains forward-looking statements, including
statements regarding the commercialization and commercial availability
of NERLYNX® in Israel; the registration of, and regulatory
approval of, NERLYNX in the region; the expected milestone payments and
royalties payable under the agreement with Medison Pharma Ltd.; the
benefits of NERLYNX and neratinib; the Company’s clinical trials; and
the announcement of data relative to those trials. All forward-looking
statements included in this press release involve risks and
uncertainties that could cause the Company’s actual results to differ
materially from the anticipated results and expectations expressed in
these forward-looking statements. These statements are based on current
expectations, forecasts and assumptions, and actual outcomes and results
could differ materially from these statements due to a number of
factors, which include, but are not limited to, the fact that the
Company has only recently commenced commercialization and shipment of
its only FDA approved product; the Company’s dependence upon the
commercial success of NERLYNX (neratinib); the Company’s history of
operating losses and its expectation that it will continue to incur
losses for the foreseeable future; risks and uncertainties related to
the Company’s ability to achieve or sustain profitability; the Company’s
ability to predict its future prospects and forecast its financial
performance and growth; failure to obtain sufficient capital to fund the
Company’s operations; the effectiveness of sales and marketing efforts;
the Company’s ability to obtain FDA approval or other regulatory
approvals in the United States or elsewhere for other indications for
neratinib or other product candidates; the challenges associated with
conducting and enrolling clinical trials; the risk that the results of
clinical trials may not support the Company’s drug candidate claims;
even if approved, the risk that physicians and patients may not accept
or use the Company’s products; the Company’s reliance on third parties
to conduct its clinical trials and to formulate and manufacture its drug
candidates; risks pertaining to securities class action, derivative and
defamation lawsuits; the Company’s dependence on licensed intellectual
property; and the other risk factors disclosed in the periodic and
current reports filed by the Company with the Securities and Exchange
Commission from time to time, including the Company’s Quarterly Report
on Form 10-Q for the quarter ended September 30, 2017. Readers are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. The Company assumes
no obligation to update these forward-looking statements, except as
required by law.
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